drugset / Trial / NCT02960594

hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse

NCT02960594

Non-randomizedSingle-groupOpen-labelPrevention

Summary

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

Timeline

Start
2014-12
Primary completion
2018-11-09
Completion
2018-11-09

Drugs

EvaluationDrugModalityDoseRoute
Subject INO-1401 Unknown 2 mg Intramuscular
Subject INO-1401 Unknown 8 mg Intramuscular
Subject Rocakinogene Sifuplasmid Vaccine 0.5 mg Intramuscular
Subject Rocakinogene Sifuplasmid Vaccine 2 mg Intramuscular
Subject hTERT Vaccine 2 mg Intramuscular
Subject hTERT Vaccine 8 mg Intramuscular